Grifols S A Stock Price, News & Analysis

Grifols has received a $21 million grant from The Michael J. Fox Foundation for Parkinson's Research to identify plasma-based biomarkers for early detection of Parkinson's disease (PD). The initiative, named 'Chronos-PD', will analyze longitudinal plasma samples over a 10-year period to track plasma protein evolution in PD patients.

The research aims to establish an early-warning system for PD, which currently affects nearly 1 million people in the U.S. and over 6 million worldwide. Grifols will leverage its repository of over 100 million plasma samples collected over 15 years, representing thousands of disease states connected to real-world health data.

The project will be led by Grifols subsidiary Alkahest, utilizing AI and integrative analysis of multiomics and real-world data. The initiative could potentially revolutionize PD management by enabling earlier diagnosis and development of disease-modifying therapeutics before symptoms appear.

Mason Capital Management, holding approximately 2.5% of Grifols (GRFS) class A shares, has sent a letter to the Spanish National Securities Market Commission (CNMV) highlighting concerns about transparency issues at Grifols. The letter focuses on three main areas of concern:

1. Related-party transactions involving Board member Tomas Daga and his firm Osborne Clarke Spain, which has been the primary advisor on Grifols transactions since 2014

2. Questions about Grifols' internal legal department structure, noting only 14 employees all located in the US rather than at headquarters in Barcelona

3. Concerns about a December 2024 €1.3bn bond issuance with a 7.125% interest rate, which reportedly includes special clauses benefiting Brookfield at shareholders' expense

Mason requests detailed disclosure of fees paid to Osborne Clarke Spain, Daga's ownership stakes, and the bond indenture terms, arguing that these governance issues are destroying shareholder value.

Mason Capital Management, holding 2.1% of Grifols S.A. (BME: GRF) (NASDAQ: GRFS) class A shares, has sent a letter to the Grifols Board requesting important information about Tomas Daga, a 25-year Board member and Grifols family advisor. Mason seeks transparency regarding:

- Fees paid to Osborne Clarke Spain by Grifols and amounts received by Daga over 15 years
- Daga's ownership interest in Osborne Clarke Spain
- Daga's ownership stake in Scranton Enterprises
- Any arrangements between Daga/Osborne Clarke Spain and Nomura or Proskauer Rose

Mason urges the Board to accept Daga's voluntary resignation, citing poor corporate governance and shareholder value destruction. The firm emphasizes that this information is important for shareholders to evaluate Daga's suitability for continued Board service.

Mason Capital Management, holding 2.1% of Grifols (GRFS) class A shares, has sent a letter criticizing the company's board for corporate governance issues and poor capital allocation decisions. Mason demands the addition of Paul Herendeen to the Board to restore independent oversight. The letter highlights concerns about conflicts of interest, particularly regarding Tomas Daga's role in major transactions and Osborne Clarke Spain's involvement. Mason argues that recent acquisitions like Biotest have contributed to a ~50% destruction of shareholder value. The firm opposes a rumored Brookfield take-private bid at €10.50 per share, stating it significantly undervalues the company.

Mason Capital Management, holding 2.1% of Grifols (GRFS) Class A shares, sent a critical letter to the Board highlighting corporate governance failures and value destruction. The letter opposes a rumored Brookfield transaction that allegedly undervalues the company. Mason criticizes the Board's history of poor capital allocation, citing €4.5 billion in debt-financed acquisitions since 2014 that only added €136 million in EBITDA. The investor points out conflicts of interest, particularly regarding board member Tomas Daga and Osborne Clarke Spain's involvement in multiple transactions. Mason calls for immediate implementation of corporate governance reforms and suggests the company is worth €20+ per share versus the rumored €12 Brookfield offer.

Grifols (NASDAQ:GRFS) has received FDA approval for its Fibrin Sealant (FS) to treat surgical bleeding in pediatric patients in the United States. The plasma-protein based solution, marketed as VISTASEAL™ in the U.S. and Canada and VERASEAL™ in Europe, combines fibrinogen and thrombin to promote hemostasis and tissue sealing during surgery.

The approval follows successful phase 3b study results showing >95% efficacy rate in achieving hemostasis within four minutes of application. The study involved 178 patients across 18 recruitment centers. The product is distributed through a strategic collaboration with Johnson & Johnson MedTech and is currently available in 18 countries.

Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS) has partnered with BARDA to test ocular surface immunoglobulin (OSIG) eye drops for treating sulfur mustard-induced eye injury. This initiative aims to evaluate the nonclinical efficacy of OSIG in neutralizing symptoms from sulfur mustard exposure, a chemical warfare agent. If successful, it could lead to FDA approval for one of the first medical treatments for sulfur mustard ocular injury.

Grifols is repurposing an investigational OSIG therapeutic currently in development for dry eye disease (DED). The company plans to start a phase 2 clinical trial for DED in the first half of 2025. The research will investigate OSIG's anti-inflammatory properties and its ability to prevent the immune system from attacking self-antigens modified by sulfur mustard exposure.

This partnership follows Grifols' subsidiary GigaGen's recent contract with BARDA, worth up to $135 million, to develop recombinant polyclonal antibody therapies for biothreats including botulinum neurotoxins.

Grifols (GRFS) has received FDA approval for an expanded label for XEMBIFY®, its 20% subcutaneous immunoglobulin (SCIg) treatment. The new label includes treatment-naïve patients with primary humoral immunodeficiencies (PI), making XEMBIFY the first and only 20% SCIg with this extended label. This allows patients to start SCIg therapy without initial intravenous administration.

The approval also includes biweekly dosing, supported by phase 4 clinical trial data showing non-inferiority in total Ig levels compared to weekly administration. The expanded label aims to provide greater flexibility and convenience for patients. Grifols plans to launch the new label in the U.S. in Q3 2024, aligning with its strategy to increase XEMBIFY adoption and strengthen its position in the growing Ig market for immunodeficiencies.

Biotest, a Grifols Group company, has projected USD 1 billion in U.S. sales of its FDA-approved intravenous immunoglobulin, Yimmugo®, over the next seven years. Expected to launch in Q1 2025, Yimmugo will be distributed by Kedrion in the U.S. This marks Grifols' expansion in the U.S. market for immunodeficiency treatments, leveraging its existing portfolio and new proteins like fibrinogen and trimodulin, both in late-stage development. Yimmugo is the first Biotest product from their new FDA-certified facility in Germany, enhancing Grifols' strategy to meet rising demand for immunoglobulins.